- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07604155
Maxillary Sinus Augmentation Using CAD/CAM Allogenic Bone Blocks Versus Particulate Allogenic Grafts
Maxillary Sinus Augmentation Using CAD/CAM Customized Allogenic Bone Blocks Versus Particulate Allogenic Grafts for Delayed Implant Placement: A Randomized Clinical Trial
28 patients will be included in this study with atrophic posterior maxillary ridge due to sinus pneumatization who will randomly assigned to two groups
- Group I: sinus lifting using CAD/CAM allogenic block through lateral window technique
- Group II: sinus lifting using particulate allogenic graftthrough lateral window technique
Study Overview
Status
Conditions
Detailed Description
28patients will be included in this study with an atrophic posterior maxillary ridge due to sinus pneumatization, who will be randomly assigned to two groups
- Group I: sinus lifting using CAD/CAM allogenic block through lateral window technique
- Group II: sinus lifting using particulate allogenic graft through the lateral window technique
- Surgical procedure: A full-thickness, wide mucoperiosteal flap was elevated buccally. Alateral bony window of the maxillary sinus will be made then the sinus lining will be elevated carefully. The CAD/CAM allogenic block will be inserted and fixed in its position via a titanium screw to the crest of maxillary ridge (group I). In group II the particulate bone will be packed at the site of augmentation
The lateral window will be covered with collagen membrane, the flap will reposited in its place and sutured.
6 months later, implants will be inserted
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt, 3111
- Faculty of Dentistry, Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- above 20 years
- ridge height less than or equal to 5 mm
- healthy clear sinus
Exclusion Criteria:
- systemic disease affect bone healing
- heavy smokers
- disease or pathology within the sinus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CAD/CAM allogenic block
sinus lifting using CAD/CAM allogenic block through lateral window technique
|
A full-thickness, wide mucoperiosteal flap was elevated buccally. A lateral bony window of the maxillary sinus will be made, then the sinus lining will be carefully elevated. The CAD/CAM allogenic block will be inserted and fixed in its position via a titanium screw to the crest of maxillary ridge (group I). • The lateral window will be covered with collagen membrane, the flap will be repositioned in its place and sutured. |
|
Experimental: particulate allogenic graft
sinus lifting using particulate allogenic graft through lateral window technique
|
In group II the particulate bone will packed at the site of augmentation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone height gain
Time Frame: 6 months
|
using CBCT
|
6 months
|
|
marginal bone resorption around implants
Time Frame: 6 months
|
CBCT
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: mohamed h helal, lecturer, Tanta University
- Principal Investigator: rehab ghouraba, professor, Tanta University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- abcd (CardioDx)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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